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Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial
DC Field | Value | Language |
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dc.contributor.author | 손주혁 | - |
dc.date.accessioned | 2023-03-21T07:24:43Z | - |
dc.date.available | 2023-03-21T07:24:43Z | - |
dc.date.issued | 2022-10 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/193356 | - |
dc.description.abstract | Purpose: Patients with pretreated estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer have poor prognosis. Elacestrant is a novel, oral selective ER degrader that demonstrated activity in early studies. Methods: This randomized, open-label, phase III trial enrolled patients with ER-positive/HER2-negative advanced breast cancer who had one-two lines of endocrine therapy, required pretreatment with a cyclin-dependent kinase 4/6 inhibitor, and ≤ 1 chemotherapy. Patients were randomly assigned to elacestrant 400 mg orally once daily or standard-of-care (SOC) endocrine monotherapy. Primary end points were progression-free survival (PFS) by blinded independent central review in all patients and patients with detectable ESR1 mutations. Results: Patients were randomly assigned to elacestrant (n = 239) or SOC (n = 238). ESR1 mutation was detected in 47.8% of patients, and 43.4% received two prior endocrine therapies. PFS was prolonged in all patients (hazard ratio = 0.70; 95% CI, 0.55 to 0.88; P = .002) and patients with ESR1 mutation (hazard ratio = 0.55; 95% CI, 0.39 to 0.77; P = .0005). Treatment-related grade 3/4 adverse events occurred in 7.2% receiving elacestrant and 3.1% receiving SOC. Treatment-related adverse events leading to treatment discontinuations were 3.4% in the elacestrant arm versus 0.9% in SOC. Nausea of any grade occurred in 35.0% receiving elacestrant and 18.8% receiving SOC (grade 3/4, 2.5% and 0.9%, respectively). Conclusion: Elacestrant is the first oral selective ER degrader demonstrating a significant PFS improvement versus SOC both in the overall population and in patients with ESR1 mutations with manageable safety in a phase III trial for patients with ER-positive/HER2-negative advanced breast cancer. Trial registration: ClinicalTrials.gov NCT03778931. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / adverse effects | - |
dc.subject.MESH | Breast Neoplasms* / drug therapy | - |
dc.subject.MESH | Breast Neoplasms* / genetics | - |
dc.subject.MESH | Breast Neoplasms* / metabolism | - |
dc.subject.MESH | Cyclin-Dependent Kinase 4 | - |
dc.subject.MESH | Estrogen Antagonists / therapeutic use | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Receptor, ErbB-2 / metabolism | - |
dc.subject.MESH | Receptors, Estrogen / metabolism | - |
dc.subject.MESH | Tetrahydronaphthalenes | - |
dc.title | Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Francois-Clement Bidard | - |
dc.contributor.googleauthor | Virginia G Kaklamani | - |
dc.contributor.googleauthor | Patrick Neven | - |
dc.contributor.googleauthor | Guillermo Streich | - |
dc.contributor.googleauthor | Alberto J Montero | - |
dc.contributor.googleauthor | Frédéric Forget | - |
dc.contributor.googleauthor | Marie-Ange Mouret-Reynier | - |
dc.contributor.googleauthor | Joo Hyuk Sohn | - |
dc.contributor.googleauthor | Donatienne Taylor | - |
dc.contributor.googleauthor | Kathleen K Harnden | - |
dc.contributor.googleauthor | Hung Khong | - |
dc.contributor.googleauthor | Judit Kocsis | - |
dc.contributor.googleauthor | Florence Dalenc | - |
dc.contributor.googleauthor | Patrick M Dillon | - |
dc.contributor.googleauthor | Sunil Babu | - |
dc.contributor.googleauthor | Simon Waters | - |
dc.contributor.googleauthor | Ines Deleu | - |
dc.contributor.googleauthor | José A García Sáenz | - |
dc.contributor.googleauthor | Emilio Bria | - |
dc.contributor.googleauthor | Marina Cazzaniga | - |
dc.contributor.googleauthor | Janice Lu | - |
dc.contributor.googleauthor | Philippe Aftimos | - |
dc.contributor.googleauthor | Javier Cortés | - |
dc.contributor.googleauthor | Shubin Liu | - |
dc.contributor.googleauthor | Giulia Tonini | - |
dc.contributor.googleauthor | Dirk Laurent | - |
dc.contributor.googleauthor | Nassir Habboubi | - |
dc.contributor.googleauthor | Maureen G Conlan | - |
dc.contributor.googleauthor | Aditya Bardia | - |
dc.identifier.doi | 10.1200/JCO.22.00338 | - |
dc.contributor.localId | A01995 | - |
dc.relation.journalcode | J01331 | - |
dc.identifier.eissn | 1527-7755 | - |
dc.identifier.pmid | 35584336 | - |
dc.identifier.url | https://ascopubs.org/doi/10.1200/JCO.22.00338 | - |
dc.contributor.alternativeName | Sohn, Joo Hyuk | - |
dc.contributor.affiliatedAuthor | 손주혁 | - |
dc.citation.volume | 40 | - |
dc.citation.number | 28 | - |
dc.citation.startPage | 3246 | - |
dc.citation.endPage | 3256 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL ONCOLOGY, Vol.40(28) : 3246-3256, 2022-10 | - |
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